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Unoprostone isopropyl - Generic Drug Details
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What are the generic sources for unoprostone isopropyl and what is the scope of patent protection?
Unoprostone isopropyl
is the generic ingredient in one branded drug marketed by Sucampo Pharma Llc and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Unoprostone isopropyl has twenty-one patent family members in eighteen countries.
There are four drug master file entries for unoprostone isopropyl.
Summary for unoprostone isopropyl
| International Patents: | 21 |
| US Patents: | 1 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 4 |
| Bulk Api Vendors: | 21 |
| Clinical Trials: | 1 |
| Patent Applications: | 1,270 |
| DailyMed Link: | unoprostone isopropyl at DailyMed |
Recent Clinical Trials for unoprostone isopropyl
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sucampo Pharmaceuticals, Inc. | Phase 2 |
Paragraph IV (Patent) Challenges for UNOPROSTONE ISOPROPYL
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| RESCULA | SOLUTION/DROPS;OPHTHALMIC | unoprostone isopropyl | 021214 | 2014-05-12 |
US Patents and Regulatory Information for unoprostone isopropyl
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sucampo Pharma Llc | RESCULA | unoprostone isopropyl | SOLUTION/DROPS;OPHTHALMIC | 021214-001 | Aug 3, 2000 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for unoprostone isopropyl
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sucampo Pharma Llc | RESCULA | unoprostone isopropyl | SOLUTION/DROPS;OPHTHALMIC | 021214-001 | Aug 3, 2000 | Start Trial | Start Trial |
| Sucampo Pharma Llc | RESCULA | unoprostone isopropyl | SOLUTION/DROPS;OPHTHALMIC | 021214-001 | Aug 3, 2000 | Start Trial | Start Trial |
| Sucampo Pharma Llc | RESCULA | unoprostone isopropyl | SOLUTION/DROPS;OPHTHALMIC | 021214-001 | Aug 3, 2000 | Start Trial | Start Trial |
| Sucampo Pharma Llc | RESCULA | unoprostone isopropyl | SOLUTION/DROPS;OPHTHALMIC | 021214-001 | Aug 3, 2000 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for unoprostone isopropyl
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Africa | 200207140 | Start Trial |
| Russian Federation | 2002127733 | Start Trial |
| Hungary | 0300391 | Start Trial |
| Mexico | PA02008967 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for unoprostone isopropyl
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0289349 | C300135 | Netherlands | Start Trial | PRODUCT NAME: UNOPROSTONEZUUR, DESGEWENST IN DE VORM VAN EEN ESTER OF EEN ZOUT; NATL REGISTRATION NO/DATE: RVG 28628 20030708; FIRST REGISTRATION: FR 359 911-5 AND 359 912-1 20020917 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
